BEUDAMED
    FDA Enforcement Class II Terminated

    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

    Recall: Z-1485-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1485-2020
    Event ID
    85080
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise N.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    March 25, 2020
    Initiation Date
    February 3, 2020
    Classification Date
    March 13, 2020
    Termination Date
    March 20, 2020
    Address
    Technologielaan 15, Heverlee, N/A, Belgium

    Description

    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013

    Reason

    Custom surgical kits contain a plate different than indicated by the package labeling.

    Code Info

    Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK

    Distribution

    US: NY. OUS: Italy

    Quantity

    1